Abstract: An embodiment of a system includes a power source and at least two electrode assembles. The power source that an output current that alternates between a maximum current value and a minimum current value; a pair of electrode assemblies. Each electrode assembly is configured to be held in contact with a skin layer of a user. Additionally, each electrode assembly includes an electrode that is coupled to the power source to receive the output current from the power source. At least one of the electrode assemblies in the pair includes a medium that carries an active agent having a charge, the medium being provided on the at least one electrode assembly to enable the output current to repel the active agent into the skin layer for a duration in which the output current has a polarity that is the same as a polarity of the active agent.

Abstract: Embodiments of the invention provide apparatus, systems and methods for detecting neurological activity indicative of a dream state of a human. Many embodiments of the invention provide apparatus, systems and methods for detecting neurological activity of a human indicative of a dream state or the onset thereof and delivering an input to the user (such as an audio or other sensory input) during the dream state. Particular embodiments of the invention provide systems and methods for detecting neurological activity indicative of the onset or occurrence of a dream state of a human and delivering an audio or other sensory input during the user's dream state. The audio input may be used for learning, delivering messages to the user's subconscious, and/or promoting a state of relaxation.

Abstract: A system for controlling urination in a patient includes an implantable controller and an external device. The implantable controller includes circuitry and electrodes for stimulating the pudenal nerves in order to control urination. In addition, the implantable controller includes sensors for determining information on bladder fullness and for transmitting such information to an external device which is used for controlling the implanted controller. The external device will display when bladder filling exceeds a safe threshold level, allowing the patient and a caregiver to take appropriate steps to allow the patient to urinate.

Abstract: Embodiments of the invention provide shaped masses (SM) comprising one or more drugs such as proteins or polypeptides and methods for forming and delivering such SM's. One embodiment provides a SM comprising a drug e.g., a protein or polypeptide having a biological activity in the body of a mammal. The SM is formed by compression of a precursor material (PM) comprising the drug wherein an amount of biologically active drug in the SM is a minimum level to that in the PM. Drugs which may be incorporated into the SM include insulin, incretins and immunoglobulins e.g., interleukin neutralizing antibodies or TNF-?-inhibiting antibodies. Embodiments of the invention are particularly useful for the oral delivery of drugs which would be degraded within the GI tract, wherein the SM containing the drug is formed as or incorporated into a tissue penetrating member which is inserted into the intestinal wall after oral ingestion.

Abstract: Embodiments provide swallowable devices, preparations and methods for delivering viable cells (VC) into the GI tract including GI wall tissue or other tissue site. Particular embodiments provide a swallowable device such as a capsule for delivering VC into an intestinal wall or other site. The VC can be contained within a tissue-penetrating shell disposed in the capsule that protects the VC as they pass through the GI tract until they are inserted into GI tract tissue or other location. The shell desirably has shape, size and material consistency to be contained in a swallowable capsule, delivered from the capsule into solid tissue by the application of force on the shell and biodegrade within the solid tissue to release the VC into the tissue. Within the shell or other structure the VC can be maintained in a viability-sustaining gel that preserves the viability of the VC for selected time periods.

Abstract: Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

Abstract: Various embodiments described herein provide an apparatus system, and method for detecting and treating various neurological events or conditions such as epilepsy and migraine headaches which are associated with cortical spreading depression (CSD). Also, many embodiments provide an apparatus, system and method for delivery of a drug such as a loop diuretic to prevent or reduce the duration of a seizure or other event associated with CSD. The drug may delivered intra-cranially in a dose selected to produce a localized effect in the brain to prevent or reduce the duration of the seizure or other event while minimizing adverse peripheral effects such as diuresis or electrolyte loss.

Abstract: Embodiments provide swallowable devices, preparations and methods for delivering therapeutic agents (TAs) within the GI tract such as antibodies (AP-antibodies) or other proteins which neutralize PCSK9 molecules. Many embodiments provide a swallowable device e.g., a capsule for delivering TAs into the intestinal wall (IW). Embodiments also provide TA preparations that are configured to be contained within the capsule, advanced from the capsule into the IW and/or peritoneum and degrade to release the TA into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the IW. Embodiments are particularly useful for delivery of AP-antibodies and related TA's for the treatment of cholesterol, lipid and related conditions where such TAs are poorly absorbed and/or degraded within the GI tract.

Abstract: Various embodiments of the invention provide a buoy and system for monitoring divers and other underwater objects. In many embodiments, the buoy has capabilities to monitor a diver, obtain position information about the diver and use that information to move itself to an effective range for continued monitoring. The buoy can connect and communicate with a communication device attached to a diver to communicate, position, biometric and other data. In one embodiment, the buoy comprises a propulsion system for propelling the buoy, an acoustic communication module for communicating with the diver and a propulsion controller for controlling the propulsion system to move to the effective range. Other embodiments provide a power generation system using a power generating buoy comprising an inertial weight, an energy converter and a connecting linkage. The system may comprise a single or multiple buoys and can include an electrical storage such as an electrical battery.

Abstract: Embodiments of the invention provide drug packaging and methods for producing drug packaging which can be sealed at room temperature and/or without the need for elevated temperatures above room temperature. Many embodiments provide drug packaging comprising pierceable tubing having a capsule shape (also referred to herein as a pierceable capsule and/or pierceable drug capsule) containing a solid drug such as a drug pellet and methods for producing pierceable drug capsules which can be sealed at room temperature. Embodiments are particularly useful for the packaging and delivery of drugs used in implantable drug delivery devices as well as packaging of drugs that are easily thermally degraded.

Abstract: Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

Abstract: Embodiments of the invention provide apparatus, systems and methods for detecting neurological activity indicative of a dream state of a human. Many embodiments of the invention provide apparatus, systems and methods for detecting neurological activity of a human indicative of a dream state or the onset thereof and delivering an input to the user (such as an audio or other sensory input) during the dream state. Particular embodiments of the invention provide systems and methods for detecting neurological activity indicative of the onset or occurrence of a dream state of a human and delivering an audio or other sensory input during the user's dream state. The audio input may be used for learning, delivering messages to the user's subconscious, and/or promoting a state of relaxation.

Abstract: Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

Abstract: Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

Abstract: Embodiments provide apparatus and methods for delivering liquid form medication within the body wherein the medication is stored in solid form and then mixed with a liquid in an apparatus implanted within the body. One embodiment provides an implantable apparatus for in vivo delivery of medication comprising a housing including a reservoir, a store of solid form medication (SSM) and a pump. An SSM element is added to the reservoir along with fluid to form a medication solution comprising at least one drug. The medication solution is then delivered to a delivery site using a pumping means to pump solution from the reservoir through a delivery member such as catheter to a delivery site. Embodiments of the invention are particularly useful for delivering medication to a patient to treat a medical condition over an extended period of time without requiring the patient to take external medication.

Abstract: Embodiments of the invention provide compositions comprising bio degradable polymers, medical implants fabricated from these compositions and methods of using such implants. Many embodiments provide medical implants comprising a first polymer backbone having a first rate of biodegradation and a second polymer backbone having a second rate of biodegradation faster than the first rate. In some embodiments, the second backbone is configured to be replaced by a natural tissue layer. The first backbone provides a scaffold for the implant while the second backbone degrades. This scaffold can enhance mechanical properties of the implant including various aspects of mechanical strength such as tensile, bending, hoop and yield strength; and elasticity. The scaffold also serves to maintain a minimum level of structural support of the implant during the period of degradation of the second backbone or for the entire life of the implant so that the implant does not mechanically fail.

Abstract: Embodiments of the invention provide methods and apparatus for using a controllable heat source to generate electricity. One embodiment provides an energy generation module comprising a controllable heat source, one or more jackets of thermoelectric devices, and heat conducting fluids surrounding or otherwise thermally coupled to the jackets. The energy generation module can be used to convert heat from a heat source such as a gas combustion chamber into electricity. Embodiments of the invention are particularly useful for generating electricity when electrical power is not existent, cost prohibitive or otherwise in short supply. The generated electricity can be used by the user, stored in an electrical storage battery or sold to a local or remote power grid.

Abstract: Embodiments of the invention provide apparatus, methods and systems for delivering treatments and for medications to the site of an aneurysm (SOA). One embodiment of a method comprises delivering a neural growth stimulating factor (NGSF) to the site of the aneurysm to grow new nerve cells and/or stimulate the regeneration of damaged nerve cells. The NGSF may be delivered in a carrier such as a gel which can be selected to allow for long term delivery of the NGSF to the SOA. In many embodiments, the NGSF may be delivered to the SOA using a micro-catheter based system which includes a microcatheter that can be advanced in the cerebral vasculature. The microcatheter may also be used to delivery occlusive element to the SOA such as occlusive coils or balloon which promote clotting and reduce bleeding at the SOA and together with the carrier allow for long term release of NGSF.

Abstract: Embodiments of the invention provide multi-stage biodegradable drug delivery platforms and methods for the subcutaneous delivery of therapeutic agents (TA). Embodiments of the platform may be configured to subcutaneously deliver a first dose of a first TA which is absorbed into the body and/or blood stream (BBS) to produce a first therapeutic effect for a first selectable time period (STP), and subsequently after a second STP, deliver a second dose of a second TA which is absorbed into the BBS to produce a second therapeutic effect for a third STP. An embodiment of the platform may comprise a body having a tissue-penetrating end, a primary cavity having a first TA dose and a shell having a secondary cavity having a second TA dose. The first TA dose is released after the first STP and the second TA dose is released after the second STP by biodegradation of the shell.

Abstract: Embodiments of the invention provide systems and methods for delivering therapeutic compositions to the inner-ear to treat inner-ear disorders. An embodiment of such a system comprises a sheath for insertion into the auditory canal and a cannula which can be inserted through the sheath. The cannula can include a tip for piercing the tympanic membrane and delivering the composition to an inner-ear tissue surface. The system may also include a therapeutic composition comprising a therapeutic agent and a thixotropic material which allows the composition to be delivered (e.g., by injection) through the cannula in liquid form and transition to gel-form once delivered to the tissue surface. A method for using the system comprises introducing the sheath into the ear, introducing the cannula through the sheath to pierce the tympanic membrane and position the tip adjacent an inner-ear tissue surface; and delivering the composition through the cannula to adhere to the tissue surface.